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    Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009

    Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25. The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code MHX·July 23, 2009

    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    FDA Recall
    Terminated ·GE Healthcare·Product code IOL·February 16, 2015

    CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.

    FDA Recall
    Terminated ·Cook Inc.·Product code KRA·November 8, 2019

    CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.

    FDA Recall
    Terminated ·Cook Inc.·Product code KRA·November 8, 2019

    CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.

    FDA Recall
    Terminated ·Cook Inc.·Product code KRA·November 8, 2019

    CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

    FDA Recall
    Terminated ·Cook Inc.·Product code KRA·November 8, 2019

    Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.

    FDA Recall
    Terminated ·Accuray Incorporated·Product code IYE·March 19, 2013

    IVEA Product Part Number 16100 Model 500A

    FDA Recall
    Terminated ·Firefly Medical, Inc.·Product code FOX·August 24, 2017

    StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Recall
    Open, Classified ·Stimwave Technologies Inc·Product code GZF·July 15, 2020

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Recall
    Open, Classified ·Stimwave Technologies Inc·Product code GZF·July 15, 2020

    StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Recall
    Open, Classified ·Stimwave Technologies Inc·Product code GZF·July 15, 2020

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Recall
    Open, Classified ·Stimwave Technologies Inc·Product code GZF·July 15, 2020

    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Recall
    Open, Classified ·Stimwave Technologies Inc·Product code GZF·July 15, 2020

    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Recall
    Open, Classified ·Stimwave Technologies Inc·Product code GZF·July 15, 2020

    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJW·July 16, 2024

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·May 2, 2018

    Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020